Sterile Vessel is made as per WHO & USFDA standards of manufacture sterile solutions. It is available in various configuration with instrumentation from manual operation to full automation. it is designed and fabricated as per ASME BPE & EHEDG guideline to meet cGMP & USFDA requirement.
- EYE DROP SUSPENSIONS
- INFUSION SOLUTIONS
- BACTERIA AND CELL CULTURE
- I.V FLUIDS
- PLASMA FRACTIONS
KEY FEATURES of Sterile Vessel
- Customized Aseptic Design as per US FDA / cGMP / ASME/ PED/ compliance with ASME – BPE norms
- Vessel Design with CIP/SIP able accessories.
- Magnetic/High Sheer mixer bottom mounted with speed variation from 50 to 400 RPM
- Outlet valve Zero dead leg type with sampling/sterilization configurations
- Sampling valve zero dead leg type with CIP/SIP able.
- Block valves for dead leg compliance and compactness
- Sterile flange connections of top dish/side ports to enhance CIP / SIP operation
- pH, temperature, conductivity, DO sensing through the sanitary port on the vessel shell
- Components and instruments from reputed international vendors
- Interconnected product piping through sampling systems and pumps with filtration skids
- Load cell for weight measurement / Level sensors for level measurements
- Variable speed drive for control of mixing speed.
We design an automation system that is reliable, easy to operate, connects and sequences the processes seamlessly. Our system design ensures different equipment’s work together in proper sequence.
Automation that is driven by highly reliable and accurate instruments and controls deliver consistency and repeatability. A highly skilled, experienced and well trained electrical & automation team works together with process specialists to design automation sequences that are implemented and rigorously tested.
- 21 CFR part 11 compliant, fully automated PLC controlled touch screen HMI
- HMI / IPC controls for localized control.
- PLC-SCADA open solution
- As per GAMP 5 guidelines.
The cleaning characteristics of Sterile vessels are key right from the start of the design process. It is essential to eliminate dead-leg areas and ensure that Clean-in-Place (CIP) and Sterilize-in-Place (SIP) systems are effective.
Cleaning capability is then verified in practice, using a Riboflavin test, for every vessel supplied.
Quality Control & Testing
Throughout the manufacturing process, all vessels are subject to stringent quality checks. An overall test forms part of the FAT (Factory Acceptance Tests) procedures and the relevant documentation forms part of the FAT protocols.
Material traceability of vessel parts and components:
Our quality system ensures the full traceability of all materials used including the provision of certificates.
- 5 – 30,000 Litres.
We supply and export in the following countries:
- Latin America